Definition

A preparation of allogeneic, off-the-shelf (OTS), universal, gene-edited T lymphocytes expressing a chimeric antigen receptor (CAR) targeting the tumor-associated antigen (TAA) CD19, with potential immunomodulating and antineoplastic activities. Upon administration, allogeneic anti-CD19 universal CAR-T cells CTA101 specifically target and bind to CD19-expressing tumor cells, thereby selectively lysing CD19-expressing tumor cells. CD19 antigen is a B-cell specific cell surface antigen overexpressed in B-cell lineage malignancies. CTA101 is genetically engineered to prevent graft-versus-host disease (GvHD) by the donor T cells. OTS CAR-T cells require reduced production times when compared to autologous CAR-T cells.